Exercise as Adjunctive Treatment for Refractory Epilepsy

NCT04607317 | Terminated DMC

• 1 other identifier: IRB00068408
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy. The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.

Conditions

Refractory Epilepsy; Epilepsy

Keywords

exercise; telehealth; adjunctive treatment

Outcome Measures

Primary Outcomes (2)

• Proportion of participants recruited

  This outcome measure assesses Feasibility of Recruitment. Recruitment will be calculated as a percentage by dividing the total number of enrolled participants by the total number of eligible participants.

  Week 0 Baseline

• Proportion of participants completing all visits

  This outcome measure assesses Feasibility of Retention. Retention will be calculated as the percentage of all participants who complete Visit 2 Week 16 (End of Intervention) out of the total number of participants enrolled.

  Visit 3 (Week 16 after Baseline)

Secondary Outcomes (3)

• Proportion of Participants who achieve their target

  Visit 3 (Week 16 after Baseline)

• Acceptability of the Intervention Questionnaire

  Week 16 and Week 28 after baseline

• Percentage of participants achieving the goal for at least 10 weeks

  Week 28 after baseline

Other Outcomes (17)

• Heart Rate Variability (HRV) measurement

  baseline and Visit 3 (week 16 after baseline)

• Perceived Stress Scale (PSS)

  baseline, week 16 after baseline, week 28 after baseline

• Pittsburgh Sleep Quality Index (PSQI)

  baseline, week 16 after baseline, week 28 after baseline

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

Participants in this arm will be enrolled in a telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day). Participants will meet weekly 1:1 with a trained health coach via a Webex platform. Weekly exercise goals will be tailored to the individual's abilities and specific barriers. Coaching will utilize social cognitive theory and self-determination theory to develop self-efficacy for sustainable behavior change.

Behavioral: Exercise program; Behavioral: Health Coach

Control

ACTIVE COMPARATOR

Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks. They will continue to wear the Garmin activity tracker and can view their activity but will not be given an exercise program. They will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene.

Behavioral: Health Information

Interventions

Exercise program BEHAVIORAL

a telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day)

Exercise Intervention

Health Coach BEHAVIORAL

The coach will work directly with each participant during their once-weekly virtual 1:1 meeting to progress intensity and duration. Participants will meet with the coach to review a brief social cognitive theory-based module, which will provide education on core behavior change concepts and the benefits of physical activity for those with epilepsy. The coach will review the previous week's exercise during meetings, and will then work with the participant to revise and reset goals for the coming week.

Exercise Intervention

Health Information BEHAVIORAL

Participants will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Focal or generalized epilepsy, as clinically determined by a Wake Forest Baptist Health epileptologist.
• Seizure frequency of at least 1 clinically observable seizure in the year prior to enrollment
• Able to ambulate independently without assistive device
• Access to a smartphone with application capabilities
• Internet access or cellular data plan to attend virtual sessions

You may not qualify if:

• Diagnosis of nonepileptic or psychogenic spells
• Seizures associated with frequent falls with injury
• \<50% adherence with wearing the device or completing the study diary during the baseline period.
• Currently in an exercise program
• Medical conditions that would limit ability to participate in an exercise intervention such as:
• Stage III or IV Congestive Heart Failure (CHF)
• End-stage Renal Disease
• Severe dementia or significant cognitive impairment
• Uncontrolled hypertension (HTN)
• Motor conditions that limit ambulation

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Halley Alexander, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants will not be blinded as to whether they are in the intervention or control group. Blinded study staff will perform all pre-and post outcome assessments. The PI will also be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to exercise intervention arm or control arm.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: April 13, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)